Label: MEDI FIRST SINUS PAIN AND PRESSURE- acetaminophen, phenylephrine hydrochloride tablet
OTIS CLAPP MYGREX- acetaminophen, phenylephrine hydrochloride tablet
MEDI FIRST PLUS SINUS PAIN AND PRESSURE- acetaminophen, phenylephrine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 16, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Acetaminophen 500mg

    Phenylephrine HCl 5mg

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    temporarily relieves these common cold/flu symptoms:

    • nasal congestion
    • headache
    • minor aches and pains
    • stuffy nose
    • sinus congestion and pressure

    temporarily reduces fever

  • WARNINGS

    Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
    • for more than 10 days for pain unless directed by a doctor

    Ask a doctor before use if you have

    • liver disease
    • thyroid disease
    • diabetes
    • high blood pressure
    • heart disease
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin

    When using this product do not exceed recommended dosage.

    Stop use and ask a doctor if

    • you get nervous, dizzy, or sleepless
    • pain or nasal congestion gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms appear

    These could be signs of a serious condition.

    If pregnant or breast feeding, ask a health professional before use.

    Keep out of reach of children.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not use more than directed

    Adults and children: (12 years and over) Take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.

    Children under 12 years: Ask adoctor

  • OTHER SAFETY INFORMATION

    Other information

    • store at room temperature 59º-86ºF (15º-30ºC)
    • tamper evident sealed packets
    • do not use any opened or torn packets
    • avoid excessive heat and humidity
  • INACTIVE INGREDIENT

    Inactive ingredients corn starch, crospovidone*, FD&C blue #1*, hypromellose*, microcrystalline cellulose, polyethylene glycol*, povidone, pregelatinized starch*, sodium starch glycolate*, stearic acid.

    *may contain

  • QUESTIONS

    Questions or comments? 1-800-634-7680

  • Medi-First Plus Sinus Pain and Pressure Label

    100 Tablets
    (50 x 2's)
    Medi First ® Plus
    Sinus Pain and Pressure
    Aches & Fever • Acetaminophen 500 mg

    Nasal Decongestant • Phenylephrine HCl 5 mg

    Pull to Open

    This Package is For Households Without Young Children.

    Sinus Pain Releif

    Tamper Evident

    Unit Dose Packets

    Medi-First

  • Medi-First Sinus Pain and Pressure Label

    250 Tablets
    (125 x 2)
    Medi-First ®
    Sinus Pain and Pressure

    Alivio al dolor y presion en los

    senos nasales

    Pull to Open
    Tire Para Abrir

    Aches & Fever • Acetaminophen 500 mg

    Dolores, Fiebre • Acetaminofeno 500 mg

    Nasal Decongestant • Phenylephrine HCl 5 mg

    Descongestivo nasal • Hidrocloruro de fenilefrina 5 mg

    This Package is For Households Without Young Children.

    Este Paquete Es Para Hogares Sin Ninos Pequenos.

    Tamper Evident Unit Dose Packets

    Empaquetado con Sellado Rvidente en Dosis Unitarias

    MF Sinus

  • Otis Clapp Mygrex Label

    Otis Clapp
    Quality and Integrity Since 1840
    MYGREX ™
    Pain Reliever-Decongestant
    Advanced Relief
    For Sinus/Headaches
    See Warnings and Directions on Side Panel

    This Package is for Households without Young Children.
    Acetaminophen 500 mg • Aches & Fever
    Phenylephrine HCl 5 mg • Nasal Decongestant
    Tear Out Along Perforation To Dispense
    PROFESSIONAL HEALTHCARE
    300 Tablets (150 PACKETS OF 2)

    Otis

  • INGREDIENTS AND APPEARANCE
    MEDI FIRST SINUS PAIN AND PRESSURE 
    acetaminophen, phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-146
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorblue (blue) Scoreno score
    ShapeROUND (ROUND) Size12mm
    FlavorImprint Code FR;33
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-146-3350 in 1 BOX12/30/2008
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-146-48125 in 1 BOX12/30/2008
    22 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-146-13250 in 1 BOX12/30/2008
    3NDC:47682-146-992 in 1 PACKET; Type 0: Not a Combination Product
    4NDC:47682-146-992 in 1 PACKET; Type 0: Not a Combination Product12/30/2008
    5NDC:47682-146-5025 in 1 BOX04/16/2019
    52 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/30/2008
    OTIS CLAPP MYGREX 
    acetaminophen, phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-148
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorblue (blue) Scoreno score
    ShapeROUND (ROUND) Size12mm
    FlavorImprint Code FR;33
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-148-03150 in 1 BOX12/30/2008
    1NDC:47682-148-992 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-148-992 in 1 PACKET; Type 0: Not a Combination Product12/30/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/30/2008
    MEDI FIRST PLUS SINUS PAIN AND PRESSURE 
    acetaminophen, phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-158
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorblue (blue) Scoreno score
    ShapeROUND (ROUND) Size12mm
    FlavorImprint Code FR;33
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-158-3350 in 1 BOX12/30/2008
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-158-48125 in 1 BOX12/30/2008
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/30/2008
    Labeler - Unifirst First Aid Corporation (832947092)
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